CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 439 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
Rituximab intravenous repeating dose (specific dose and schedule not stated in provided text)AI-extracted
Key inclusion· 5
  • ✓Definitive diagnosis of primary progressive multiple sclerosis (PPMS)
  • ✓Disease duration of at least 1 year
  • ✓EDSS score between 2.0 and 6.5 points at baseline
  • ✓Pyramidal or gait dysfunction with FS score ≥2.0 due to lower extremity findings
Key exclusion· 11
  • ✕Prior treatment with rituximab
  • ✕Prior treatment with lymphocyte-depleting therapies (cyclophosphamide, Campath, anti-CD4, cladribine, total body irradiation, bone marrow transplantation); mitoxantrone allowed if >12 months prior
  • ✕Active or recent major infection (IV antibiotics within 30 days or oral antibiotics within 14 days)
  • ✕History or presence of chronic infection (hepatitis B/C, HIV, syphilis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00087529
NCT00087529Phase 3Completed
CompareCT.gov

A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis

Genentech, Inc.·interventional·Posted Jul 13, 2004·Updated Sep 9, 2015

In Brief

A Phase 3 clinical trial evaluating placebo and rituximab for Multiple Sclerosis. Completed, enrolled 439 participants.

Detailed Summary

This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2004
Enrollment StartJun 1, 2004
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 22.0 years ago

Interventions

placebodrug

Intravenous repeating dose

rituximabdrug

Intravenous repeating dose